Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer

NCT07492927 | Recruiting

• 1 other identifier: KY20262014-F-1
• Study Type: observational
• Target: 1,700
• Locations: 2 countries
• Sites: 10

Brief Summary

The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.

Conditions

Clinically Significant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing csPCa

  The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing clinically significant prostate cancer (csPCa) and evaluate its sensitivity and specificity in diagnosing csPCa. Descriptive statistics were calculated and presented as the frequency (percentage) for categorical variables, the mean (standard deviation) for continuous variables with a normal distribution, and the median (quartile) for continuous variables with a skewed distribution. Two-sample t-tests were used to assess continuous variables with a normal distribution, and the Wilcoxon signed-rank test was used to assess continuous variables with a skewed distribution. The Mann-Whitney U test was used to compare means from two samples. The correlation between two samples was analyzed by Spearman's ρ test. The receiver operating characteristic (ROC) curve was used to determine the cutoff value of exo-RNA panel for diagnosing patients with csPCa.

  The time of prostate biopsy

Secondary Outcomes (1)

• Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa and its comparison with other imaging methods or blood tests

  The time of prostate biopsy

Study Arms (1)

Study Cohort

The experimental arm receiving diagnosis from serum RNA combination

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The men with suspected prostate cancer

You may qualify if:

• Blood prostate-specific antigen PSA\>4ng/dl;
• Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging.
• The patient is willing to undergo prostate biopsy.

You may not qualify if:

• Previous diagnosis of prostate cancer through prostate biopsy;
• History of other malignant tumors in the past two years;
• According to the research physician''s judgment, serious complications may occur and affect the normal conduct of the experiment

Sponsors & Collaborators

• Ningxia Medical University: collaborator
• Northwestern University: collaborator
• Yan'an University Affiliated Hospital: collaborator
• Xijing Hospital: lead
• Shaanxi Provincial People's Hospital: collaborator
• Weinan Central Hospital: collaborator
• Shaanxi University of Chinese Medicine: collaborator
• LanZhou University: collaborator
• Qinghai University: collaborator
• Air Force Military Medical University, China: collaborator

Study Sites (10)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, China

RECRUITING

Weinan Central Hospital

Weinan, Shaanxi, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

RECRUITING

Xijing 986 Hospital

Xi'an, Shaanxi, China

RECRUITING

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, Shaanxi, China

RECRUITING

Yan'an University Affiliated Hospital

Yan’an, Shaanxi, China

RECRUITING

Xijing Hospital

Xi'an, 710032, China

RECRUITING

Study Officials

• Weijun Qin, MD.

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Jianhua Jiao, MD.

CONTACT

+86 029 84771062; 1531769428@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: March 12, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9); US (1)